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Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI

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ClinicalTrials.gov Identifier: NCT01159366
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : July 12, 2010
Information provided by:

Study Description
Brief Summary:
It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.

Condition or disease Intervention/treatment Phase
NSTEMI Procedure: percutaneous coronary intervention Phase 4

Detailed Description:
We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL
Study Start Date : July 2006
Primary Completion Date : December 2009
Study Completion Date : January 2010
Arms and Interventions

Arm Intervention/treatment
Active Comparator: occluded culprit artery
An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
Procedure: percutaneous coronary intervention
early timing
Other Name: early invasive treatment strategy in NSTEMI
Active Comparator: non-occluded culprit artery
A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.
Procedure: percutaneous coronary intervention
early timing
Other Name: early invasive treatment strategy in NSTEMI

Outcome Measures

Primary Outcome Measures :
  1. MACE [ Time Frame: 6 months ]
    composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion

Secondary Outcome Measures :
  1. CK and CK-MB [ Time Frame: 48 hours ]
    Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age between 18 and 90 years,
  • onset of angina pectoris at rest <24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting <24 h,
  • elevated troponin T ≥0.03 µg/L and
  • written informed consent.

Exclusion Criteria:

  • persistent angina,
  • ST-segment elevation myocardial infarction (STEMI),
  • hemodynamic instability including cardiogenic shock,
  • oral anticoagulation therapy,
  • contraindications for glycoprotein IIb/IIIa inhibitors,
  • other disease with life expectancy <6 months,
  • known coagulopathy,
  • pregnancy,
  • other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,
  • no ability to consent, and
  • participation in another study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159366

University of Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Jena
Study Chair: Gerhard Schuler, MD, PhD University of Leipzig
More Information

Responsible Party: Holger Thiele, MD, PhD, University of Leipzig
ClinicalTrials.gov Identifier: NCT01159366     History of Changes
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: July 2010

Keywords provided by University of Jena:
myocardial infarction
coronary occlusion
myocardial revascularization

Additional relevant MeSH terms:
Non-ST Elevated Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases